SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Reported: July 8, 2015 Initiated: June 4, 2015 #Z-1933-2015
Product Description
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Reason for Recall
A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 40 total
- Distribution
- Nationwide Distribution.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 40 total.
Why was this product recalled? ▼
A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2015. Severity: Moderate. Recall number: Z-1933-2015.
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